Overview

G&L Healthcare Advisors was engaged to support post-merger activities following the merger of two major pharmaceutical companies. 

The reduction in overall regulatory headcount created significant barriers to effective product knowledge transfer, necessitating a structured approach to retain critical regulatory information.

Challenges

The client faced several key challenges during the post-merger knowledge transfer process:
Reduced regulatory headcount: The merger resulted in a significant reduction in regulatory personnel, hindering the transfer of essential product knowledge.
Knowledge silos: Critical information regarding legacy products was siloed among various dossier owners and product principles, complicating access and transfer.
Archival management: The need to identify, catalog, and transfer extensive legacy documentation from both physical and electronic archives presented logistical challenges.

G&L's Approach and Solution

G&L implemented a comprehensive approach to facilitate the effective transfer of regulatory knowledge. Key activities included:
Centralized project team: G&L assembled a centralized project team in a near-shore location to support the client’s knowledge transfer efforts post-merger, ensuring efficient collaboration and communication.
Knowledge transfer template creation: A structured product knowledge transfer template was developed to standardize the transfer process and ensure consistency across all legacy products.
Interviews with product owners: G&L conducted interviews with all product principles and dossier owners to gather critical insights and facilitate knowledge sharing.
Documentation identification: Key regulatory documentation was identified from legacy physical and electronic archives, ensuring that all pertinent information was captured.
Archival management: The entire legacy physical archive was cataloged, scanned, uploaded into a parent database, and transferred to off-site storage for easy access and retrieval.

Impacts and Outcomes

As a result of G&L’s support, the following was achieved:
Successful knowledge transfer: Regulatory knowledge for all legacy products was successfully transferred, ensuring continuity and compliance.
Comprehensive documentation archive: All legacy documentation was transferred and archived into a centralized electronic archive, enhancing accessibility for future regulatory activities.
Flexible and sensitive approach: The entire initiative was resourced in a flexible, sensitive, and apolitical manner, fostering a collaborative environment for knowledge sharing.